Alert! This chapter may be affected by an emergency rule:
Phar 7.43(6)(a)5. 5. Documentation indicating accepting responsibility for compliance with this section, signed and dated by both the managing pharmacist and supervising pharmacist, indicating the name of the supervising pharmacist, and the dates the supervision responsibilities begin and end.
Phar 7.43(6)(b) (b) The managing pharmacist at the supervising pharmacy or supervising pharmacist is responsible for all remote dispensing connected to the supervising pharmacy.
Phar 7.43(7) (7)Delegate requirements. A person engaged in the practice of pharmacy under s. 450.03 (1) (f), (g), or (i), Stats., shall meet the following requirements to remote dispense:
Phar 7.43(7)(a) (a) Be 18 years of age or older.
Phar 7.43(7)(b) (b) Be a high school graduate or have equivalent education.
Phar 7.43(7)(c) (c) Have completed 1500 hours of work as a pharmacist delegate within the 3 years prior to engaging in remote dispensing or completed an accredited pharmacy technician training program.
Phar 7.43 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (2), (4) (a) 1. made under s. 35.17, Stats., Register December 2020 No. 780.
subch. IV of ch. Phar 7 Subchapter IV — Institutional Pharmacies
Phar 7.50 Phar 7.50 Definitions. In this subchapter:
Phar 7.50(1) (1) “ Chart order” means an order entered on the chart or a medical record of an inpatient or resident of an institutional facility by a practitioner or practitioner's delegate for a drug product or device.
Phar 7.50(2) (2) “ Institutional facility” means a facility, as defined in s. 647.01 (4), Stats.; any hospital, nursing home, community-based residential facility, county home, county infirmary, county hospital, county mental health complex, or other place licensed or approved by the department of health services under s. 49.70, 49.71, 49.72, 50.03, 50.032, 50.033, 50.034, 50.35, 51.08, or 51.09, Stats.; a facility under s. 45.50, 51.05, 51.06, 146.903 (1) (b), 233.40, 233.41, 233.42, or 252.10, Stats.; a hospice facility under s. 50.90 (1) (c), Stats.; a county jail; and a correctional facility operated under the authority of the department of corrections.
Phar 7.50(3) (3) “ Institutional pharmacy” means a pharmacy that provides pharmacy services to an institutional facility. This definition is not for purposes under s. 450.09 (1) (a), Stats.
Phar 7.50 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.
Phar 7.51 Phar 7.51 Chart orders. A chart order shall contain all of the following:
Phar 7.51(1) (1) First and last name of the patient.
Phar 7.51(2) (2)Patient's medical record number or date of birth.
Phar 7.51(3) (3)Date of issuance.
Phar 7.51(4) (4)Name, strength, and form of the drug product or device prescribed.
Phar 7.51(5) (5)Directions for use.
Phar 7.51(6) (6) The signature by one of the following methods:
Phar 7.51(6)(a) (a) If handwritten, the practitioner's or delegate's signature.
Phar 7.51(6)(b) (b) Electronic signature of the practitioner or delegate.
Phar 7.51(7) (7) Chart orders prepared by a delegate of the practitioner shall include the first and last name of the delegate and the first and last name of the practitioner.
Phar 7.51 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.
Phar 7.52 Phar 7.52 Labels. All prescribed drug products and devices dispensed for administration by a health care provider at the institutional facility shall have a label attached to the container disclosing all of the following:
Phar 7.52(1) (1) Drug name, strength and form.
Phar 7.52(2) (2) Beyond use date or expiration date.
Phar 7.52(3) (3) Special storage conditions, if required.
Phar 7.52 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.
Phar 7.53 Phar 7.53 Security and access.
Phar 7.53(1)(1)Arrangements shall be made in advance by the managing pharmacist for access of drugs by the health care staff of the institutional facility when dispensing by a pharmacist is not available.
Phar 7.53(2) (2) In the absence of a pharmacist, drugs shall be stored in a manner in which only authorized personnel may obtain access and is sufficiently secure to deny access to unauthorized persons.
Phar 7.53(3) (3) The managing pharmacist shall develop policies and procedures in place to mitigate and prevent theft and diversion.
Phar 7.53 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.
Phar 7.54 Phar 7.54 Return or exchange of health items.
Phar 7.54(1)(1)In this section:
Phar 7.54(1)(a) (a) “Health item” means drugs, devices, hypodermic syringes, needles or other objects for injecting a drug product, or items of personal hygiene.
Phar 7.54(1)(b) (b) “Original container” means the container in which a health item was sold, distributed, or dispensed.
Phar 7.54(1)(c) (c) “Tamper-evident package” means a package that has one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence that tampering has occurred.
Phar 7.54(2) (2) A health item which has been sold, distributed or dispensed, may be returned to the institutional pharmacy under s. Phar 7.10 (2) or if the health item has not left the control of the health care facility staff authorized to have access to prescription drug products.
Phar 7.54(3) (3) A health item returned to an institutional pharmacy may be sold, distributed, or dispensed to the institutional facility if all of the following apply:
Phar 7.54(3)(a) (a) The health item was never in the possession and control of the patient.
Phar 7.54(3)(b) (b) The health item was sold, distributed or dispensed in a tamper-evident package and, for a drug product, includes the beyond use date or expiration date and manufacturer's lot number.
Phar 7.54(3)(c) (c) The health item is in its original container and the pharmacist determines the contents are not adulterated or misbranded.
Phar 7.54 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction in (2), (3) (intro.) made under s. 35.17, Stats., Register December 2020 No. 780.
Phar 7.55 Phar 7.55 Automated technology product verification.
Phar 7.55(1)(1)Definitions. In this section:
Phar 7.55(1)(a) (a) “Product verification” means doing a check of the accuracy and correctness of a product, including drug, strength, formulation, and expiration or beyond use date, as part of the final check.
Phar 7.55(1)(b) (b) “Supervising pharmacist” means the pharmacist licensed in this state who is responsible for the operations and outcomes of the product verification done by an automated technology.
Phar 7.55(2) (2)Automated technology product verification qualifications. Product verification may be done only by an automated technology which meets all of the following:
Phar 7.55(2)(a) (a) Located within a licensed pharmacy.
Phar 7.55(2)(b) (b) Utilizing barcodes or another machine-readable technology to complete the product verification.
Phar 7.55(2)(c) (c) Validated by the following process:
Phar 7.55(2)(c)1. 1. The automated technology shall make a product verification for accuracy and correctness of a minimum of 2500 product verifications and achieve an accuracy rate of at least 99.8%.
Phar 7.55(2)(c)2. 2. A pharmacist shall audit 100% of the product verifications made by the automated technology during the validation process.
Phar 7.55(2)(d) (d) Revalidated if the software is upgraded or any component of the automated technology responsible for the accuracy and correctness of the product verification is replaced or serviced outside of the manufacturer's standard maintenance recommendations.
Phar 7.55(3) (3)Eligible product. The automated technology may do the product verification if the product meets all of the following:
Phar 7.55(3)(a) (a) Is dispensed in the original package from a manufacturer or if a licensed pharmacist has ensured that any repackaging results in a package that is labeled with the correct drug name, strength, formulation, control or lot number, and expiration or beyond use date.
Phar 7.55(3)(b) (b) Has a drug utilization review performed by a pharmacist prior to delivery.
Phar 7.55(3)(c) (c) Will be administered by an individual authorized to administer medications at the institution where the medication is administered.
Phar 7.55(4) (4)Policies and procedures. Each pharmacy shall maintain policies, procedures, and training materials for the automated technology product verification which shall be made available to the board upon request.
Phar 7.55(5) (5)Records.
Phar 7.55(5)(a)(a) Each pharmacy shall maintain for 5 years the following records:
Phar 7.55(5)(a)1. 1. All validation records of each automated technology that include the dates that the validation occurred, the number of product verifications performed, the number of product verification errors, and overall accuracy rate.
Phar 7.55(5)(a)2. 2. Documentation indicating acceptance of responsibility for compliance with this section, signed and dated by both the managing pharmacist and supervising pharmacist, indicating the name of the supervising pharmacist and start and end dates of supervision.
Phar 7.55(5)(a)3. 3. Documentation of the completion of the manufacturer's recommended maintenance and quality assurance measures.
Phar 7.55(5)(a)4. 4. Documentation of the dates of all software upgrades.
Phar 7.55(5)(a)5. 5. Documentation of all service performed outside of the manufacturer's standard maintenance recommendations.
Phar 7.55(5)(b) (b) Records shall be made available to the board upon request.
Phar 7.55 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.
subch. V of ch. Phar 7 Subchapter V — Unlicensed Persons
Phar 7.60 Phar 7.60 Definitions.
Phar 7.60(1)(1)“Direct supervision” means immediate availability to continually coordinate, direct and inspect in real time the practice of another.
Phar 7.60(2) (2) “ General supervision” means to continually coordinate, direct and inspect the practice of another.
Phar 7.60 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21.
Phar 7.61 Phar 7.61 Persons who have completed their second year of pharmacy school or pharmacists from another state applying for licensure. A person practicing pharmacy under s. 450.03 (1) (f) or (g), Stats., is limited to performing duties under the direct supervision of a person licensed as a pharmacist by the board.
Phar 7.61 History History: CR 19-145: cr. Register December 2020 No. 780, eff. 1-1-21; correction made under s. 35.17, Stats., Register December 2020 No. 780.
Phar 7.62 Phar 7.62 Unlicensed persons.
Phar 7.62(1)(1)This section does not apply to a person practicing pharmacy under s. 450.03 (1) (f) or (g), Stats.
Phar 7.62(2) (2) A pharmacist shall provide general supervision of unlicensed personnel. A pharmacist shall be available to the unlicensed person for consultation either in person or contact by telecommunication means.
Phar 7.62(3) (3) An unlicensed person may not do any of the following:
Phar 7.62(3)(a) (a) Provide the final check on the accuracy and correctness of drug product or device dispensing under s. Phar 7.07 (1) (a) or (b), unless the person is validated for delegate-check-delegate under s. Phar 7.14.
Phar 7.62(3)(b) (b) Complete the drug utilization review under s. Phar 7.03.
Phar 7.62(3)(c) (c) Administer any prescribed drug products, devices or vaccines under s. 450.035, Stats.
Phar 7.62(3)(d) (d) Provide patient specific counseling or consultation.
Phar 7.62(4) (4) The prohibitions in sub. (3), do not apply to a person completing an internship for purposes of meeting the internship requirement under s. 450.03 (2) (b), Stats.
Phar 7.62(5) (5) A managing pharmacist shall provide training to or verify competency of an unlicensed person prior to the unlicensed person performing a delegated act.
Phar 7.62(6) (6) The managing pharmacist shall determine which acts may be delegated in a pharmacy. The managing pharmacist has a duty to notify all pharmacists practicing in that pharmacy which acts may be delegated to specific unlicensed persons. This record shall be provided to the board upon request.
Phar 7.62(7) (7) A pharmacist may delegate to an unlicensed person any delegated act approved by the managing pharmacist.
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Published under s. 35.93, Stats. Updated on the first day of each month. Entire code is always current. The Register date on each page is the date the chapter was last published.